Leforte System Bone Plate

GUDID 08806390802574

Jeil Medical Corporation

Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized

• Primary Device ID: 08806390802574
• NIH Device Record Key: 8e14bbca-8e51-4c1c-926a-39fe339d0042
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Leforte System Bone Plate
• Version Model Number: 242.50AJ16.02
• Company DUNS: 688811603
• Company Name: Jeil Medical Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806390802574 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150965

FDA Product Code

• JEY: Plate, Bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08806390802574]

Moist Heat or Steam Sterilization

[08806390802574]

Moist Heat or Steam Sterilization

[08806390802574]

Moist Heat or Steam Sterilization

[08806390802574]

Moist Heat or Steam Sterilization

[08806390802574]

Moist Heat or Steam Sterilization

[08806390802574]

Moist Heat or Steam Sterilization

[08806390802574]

Moist Heat or Steam Sterilization

[08806390802574]

Moist Heat or Steam Sterilization

[08806390802574]

Moist Heat or Steam Sterilization

[08806390802574]

Moist Heat or Steam Sterilization

[08806390802574]

Moist Heat or Steam Sterilization

[08806390802574]

Moist Heat or Steam Sterilization

[08806390802574]

Moist Heat or Steam Sterilization

[08806390802574]

Moist Heat or Steam Sterilization

[08806390802574]

Moist Heat or Steam Sterilization

[08806390802574]

Moist Heat or Steam Sterilization

[08806390802574]

Moist Heat or Steam Sterilization

[08806390802574]

Moist Heat or Steam Sterilization

[08806390802574]

Moist Heat or Steam Sterilization

[08806390802574]

Moist Heat or Steam Sterilization

[08806390802574]

Moist Heat or Steam Sterilization

[08806390802574]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-02-05
• Device Publish Date: 2015-11-23

On-Brand Devices [Leforte System Bone Plate]

• 08809282818684: 20-CV-106-F
• 08809265159834: 20-SS-018
• 08809265159827: 20-SS-013
• 08809265159810: 20-SS-008
• 08809265159803: 20-DR-018
• 08809265159797: 20-DR-013
• 08809265159780: 20-DR-008
• 08809265159773: 20-CN-009-S
• 08809265159766: 20-CN-009
• 08809265159759: 20-CN-004-S
• 08809265159742: 20-CN-004
• 08809265159735: 16-DL-012
• 08809265159728: 16-DL-007
• 08809265154969: 24L-ST-104
• 08809265154952: 24L-ST-006
• 08809265154938: 24L-RS-025
• 08809265154921: 24L-RS-021
• 08809265154914: 24L-RS-015
• 08809265154907: 24L-RR-020
• 08809265154891: 24L-RM-025
• 08809265154884: 24L-RL-020
• 08809265154877: 24L-CD-006
• 08809265154860: 24L-AR-015
• 08809265154853: 24L-AL-015
• 08809265154846: 24L-AE-104
• 08809265154839: 24L-AE-006
• 08809265154822: 24L-AE-004
• 08809265154815: 20L-ST-104-R
• 08809265154808: 20L-ST-018-R
• 08809265154792: 20L-ST-016-R
• 08809265154785: 20L-ST-010-R
• 08809265154778: 20L-ST-006-R15
• 08809265154761: 20L-ST-006-R10
• 08809265154754: 20L-ST-006-R
• 08809265154440: 20-AJ-008
• 08809265154433: 20-AJ-006
• 08809265154426: 24-SB-008
• 08809265154419: 24-SB-007
• 08809265154402: 24-SB-204
• 08809265154396: 24-SB-104
• 08809265154389: 24-SB-004
• 08809265154372: 24-RM-025
• 08809265154365: 24-RL-020
• 08809265154358: 24-RR-020
• 08809265154341: 24-RS-025
• 08809265154334: 24-RS-021
• 08809265154327: 24-RS-015
• 08809265154310: 24-AL-015
• 08809265154303: 24-AR-015
• 08809265154297: 24-CD-006